Racial Equity in Systems to Treat Opioid Use Disorder for Everyone (RESTORE): A Pilot Randomized Controlled Trial

治疗所有人阿片类药物使用障碍的系统中的种族平等（RESTORE）：一项试点随机对照试验

• 批准号: 10740668
• 负责人: Sabrina Lynn Smiley
• 金额: $ 105.35万
• 依托单位: SAN DIEGO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10740668
• 关键词: Address; Award; Black American; Black Populations; Black race; Buprenorphine; COVID-19 pandemic; California; Caring; Clinic; Clinical Trials; Communities; Competence; Disparity; Education; Evidence based intervention; Foundations; Funding; Health Services Accessibility; Healthcare; Income; Inequity; Insurance; Intervention; Investigation; Medical; Methods; National Institute of Drug Abuse; Neighborhood Health Center; Not Hispanic or Latino; Office Visits; Overdose; Patients; Phase; Prevalence; Privatization; Procedures; Protocols documentation; Provider; Publishing; Racial Equity; Randomized, Controlled Trials; Research; Role; System; Testing; Training; Underserved Population; Work; black patient; buprenorphine treatment; community engagement; design; effective therapy; feasibility testing; implementation evaluation; implementation science; improved; innovation; novel; opioid epidemic; opioid mortality; opioid overdose; opioid use disorder; overdose death; patient-level barriers; peer; provider-level barriers; racial disparity; routine care; sociologist; treatment services; underserved area

Project Summary I am a well-published, early stage medical sociologist applying for a NIDA-funded Racial Equity Visionary Award focused on the feasibility, acceptability, and preliminary efficacy of an innovative, mixed methods, community- engaged intervention targeting non-Hispanic Black (NHB) individuals with opioid use disorder (OUD). This study will apply my understanding of community needs and OUD, to test a novel intervention in a scalable setting, leveraging my role as a leader in this field to disseminate findings and improve treatment access nationwide. Opioid-related overdoses are increasing fastest in NHB individuals. In 2020, amid the COVID-19 pandemic, NHB overdose deaths increased by 45%, nearly double the increase in non-Hispanic Whites (NHW). Disproportionate increases in overdoses correspond to racial inequities in OUD treatment access and utilization. An effective treatment, buprenorphine, is concentrated among communities with high percentages of NHWs, higher income, and private insurance. Compared with NHW patients with OUD, NHB patients with OUD are 77% less likely to have an office visit that includes a buprenorphine prescription, despite similar prevalence of OUDs. This structural problem is at the foundation of my proposed research. Research focused on developing and testing culturally effective, community grounded, and structurally competent OUD treatments with rigorous implementation assessments is urgently needed to intervene on structural barriers to OUD treatment that operate in settings in which NHB individuals seek healthcare. Significant federal funding has expanded access to OUD treatment services in Community Health Centers (CHCs) that provide care to underserved populations and areas but barriers to accessing care remain in NHBs. I propose to prepare for a fully powered clinical trial by testing whether a buprenorphine treatment intervention protocol (Racial Equity in Systems to Treat Opioid Use Disorder for Everyone—RESTORE) that targets structural barriers to OUD treatment for NHB individuals is feasible in the context of CHCs. RESTORE draws upon concepts of structural competency, peer navigation, and culturally grounded OUD education for both patients and providers. Community engagement will be continuous, exemplified by the use of peer navigators to connect patients to care. RESTORE will be based in Southern California—an epicenter of the nation’s opioid crisis. Project Phases, guided by cutting edge implementation science, include 1) a qualitative investigation into provider and patient barriers to and facilitators of CHCs’ provision of buprenorphine specifically to NHB individuals with OUD; 2) the operationalization of RESTORE into routine care, using preliminary findings from Phase I; and 3) a pilot stepped-wedge randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy of RESTORE, as well as the protocols, procedures and training in CHCs. This study has the potential to improve effective treatment rates in 4 clinics and provide an evidence-based intervention to be tested at scale across multiple states. Improvements in local treatments, designed to reach NHBs, will greatly reduce the current increase in overdose disparities.

项目概要 我是一位发表了大量文章的早期医学社会学家，正在申请 NIDA 资助的种族平等远见奖 重点关注创新、混合方法、社区的可行性、可接受性和初步功效。 这项研究针对患有阿片类药物使用障碍 (OUD) 的非西班牙裔黑人 (NHB) 个体进行干预。 将运用我对社区需求和 OUD 的理解，在可扩展的环境中测试新颖的干预措施， 利用我作为该领域领导者的角色来传播研究结果并改善全国范围内的治疗机会。 2020 年，在 COVID-19 大流行期间，NHB 个体中与阿片类药物相关的过量用药增加最快。 服药过量死亡人数增加了 45%，几乎是非西班牙裔白人 (NHW) 死亡人数的两倍。 药物过量的增加与 OUD 治疗获取和利用方面的种族不平等相对应。 丁丙诺啡治疗主要集中在 NHW 比例较高、收入较高、 与患有 OUD 的 NHW 患者相比，患有 OUD 的 NHB 患者的可能性要低 77%。 尽管 OUD 的流行率相似，但仍进行了一次包含丁丙诺啡处方的就诊。 结构问题是我提出的研究的基础，重点是开发和测试。 文化有效、立足社区、结构合理的 OUD 治疗方法 迫切需要进行实施评估，以干预 OUD 治疗的结构性障碍，这些障碍 在 NHB 个人寻求医疗保健的环境中开展业务，大量联邦资金扩大了获得医疗服务的机会。 社区健康中心 (CHC) 的 OUD 治疗服务为服务不足的人群和 但 NHB 仍存在获得护理的障碍，我建议为一项全面的临床试验做好准备。 测试是否有丁丙诺啡治疗干预方案（治疗阿片类药物使用系统中的种族公平 针对 NHB 个体 OUD 治疗结构性障碍的疾病为每个人 — RESTORE 在 CHC 的背景下可能会利用结构能力、同行导航和 针对患者和提供者的社区参与的基于文化的 OUD 教育将是持续的、 例如，RESTORE 将使用同伴导航器将患者与护理机构联系起来。 加利福尼亚州——美国阿片类药物危机的中心，以最先进的实施为指导。 科学，包括 1) 对社区卫生服务提供者和患者的障碍和促进因素进行定性调查 专门向患有 OUD 的 NHB 个人提供丁丙诺啡 2) 将 RESTORE 投入使用； 常规护理，使用第一阶段的初步结果；以及 3) 一项试点阶梯楔形随机对照试验 测试RESTORE以及协议、程序的可行性、可接受性和初步功效 这项研究有可能提高 4 个诊所的有效治疗率并提供 将在多个州大规模测试基于证据的干预措施，改进当地治疗方法， 旨在达到NHBs，将大大减少目前增加的过量用药差异。